Posted by Michael Wonder on 30 Oct 2019
EMA and FDA accept marketing applications for Chugai's satralizumab in neuromyelitis optica spectrum disorder
30 October 2019 - The applications will be reviewed under accelerated assessment by EMA.
Chugai Pharmaceutical announced that the EMA has accepted the Marketing Authorization Application for satralizumab (development code: SA237), an anti-interleukin-6 (IL-6) receptor humanized recycling antibody, for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD).
The U.S. Food and Drug Administration (FDA) has also accepted the Biologics License Application (BLA) for satralizumab. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation and the FDA decision are expected in 2020.
